This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the harmonization of calibration procedures.
| Device | tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | COOPERVISION, INC. |
| Date Received | 2018-01-16 |
| Decision Date | 2018-11-23 |
| PMA | N17679 |
| Supplement | S039 |
| Product Code | LPM |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOPERVISION, INC. 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17679 | Original Filing | |
| S040 | 2018-06-07 | 30-day Notice |
| S039 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S038 | 2017-10-23 | 30-day Notice |
| S037 | 2017-09-20 | 30-day Notice |
| S036 | 2013-08-19 | 30-day Notice |
| S035 | ||
| S034 | 1999-02-23 | Normal 180 Day Track |
| S033 | ||
| S032 | 1998-02-17 | Normal 180 Day Track |
| S031 | ||
| S030 | 1995-03-29 | 30-Day Supplement |
| S029 | 1995-03-01 | Normal 180 Day Track |
| S028 | 1993-08-20 | Normal 180 Day Track |
| S027 | 1993-07-20 | Normal 180 Day Track |
| S026 | ||
| S025 | 1991-03-21 | Normal 180 Day Track |
| S024 | 1990-12-07 | Normal 180 Day Track |
| S023 | 1990-09-13 | Normal 180 Day Track |
| S022 | 1990-05-03 | Normal 180 Day Track |
| S021 | 1989-07-24 | Normal 180 Day Track |
| S020 | 1989-04-12 | Normal 180 Day Track |
| S019 | 1989-02-22 | Normal 180 Day Track |
| S018 | 1988-05-12 | Special (immediate Track) |
| S017 | 1988-03-24 | Special (immediate Track) |
| S016 | 1987-11-09 | Special (immediate Track) |
| S015 | 1987-10-26 | Normal 180 Day Track |
| S014 | 1987-10-01 | Special (immediate Track) |
| S013 | 1987-09-10 | Normal 180 Day Track |
| S012 | 1986-03-03 | |
| S011 | 1986-01-08 | |
| S010 | 1986-01-06 | |
| S009 | 1985-05-30 | |
| S008 | 1984-12-21 | |
| S007 | 1984-08-07 | |
| S006 | 1984-07-02 | |
| S005 | ||
| S004 | ||
| S003 | 1980-01-08 | |
| S002 | ||
| S001 | 1979-05-01 |